Recall Z-3245-2018— Agfa N.V.

Name: FDA recall Z-3245-2018
Creator: U.S. Food and Drug Administration
Published: 2018-08-15

Class II · Terminated

Class II FDA medical device recall by Agfa N.V., initiated 2018-08-15, terminated 2020-06-23. It names one FDA 510(k) clearance: K112670. Product: DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.. Reason: A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others..

Recalling firm: Agfa N.V.
Classification: Class II
Status: Terminated
Initiated: 2018-08-15
Terminated: 2020-06-23
Firm location: Mortsel, Belgium

510(k) clearances named in this recall

1 on FDA's record

K112670 — DX-D 600Agfa Healthcare N.V.·cleared 2011-10-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

Reason for recall

A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.

Data sourced from openFDA. This site is unofficial and independent of the FDA.